Regulatory Operations Assistant

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Operations Assistant based in United States.

This remote role supports the regulatory administration of investigational drug studies within a specialized oncology clinical research environment.
You will help maintain accurate, complete, and audit-ready Investigator Site Files and ensure essential study documentation is properly managed throughout the study lifecycle.
The position involves close coordination with investigators, study teams, monitors, institutional review boards, sponsors, and contract research organizations.
You will manage regulatory submissions, study logs, training records, safety reports, investigator credentials, and other critical documentation.
Your attention to detail and ability to keep information organized will directly support regulatory compliance and smooth clinical trial operations.
This opportunity is well suited to a highly organized professional who can work independently while maintaining consistent communication with multiple stakeholders.
You will join a collaborative environment focused on advancing clinical research and helping bring promising treatments to patients.

Accountabilities:

• Maintain paper and electronic Investigator Site Files (ISFs) for assigned investigational drug studies, including IRB submissions and approvals, study documents, correspondence, and other essential records.
• Create, update, review, and finalize Delegation of Authority logs and related systems to accurately reflect study staff changes throughout the study lifecycle.
• Obtain investigator signatures on protocols, amendments, Investigator’s Brochures, logs, and other required study-specific documents and distribute completed documentation to the appropriate sponsor or CRO contacts.
• Receive, review, process, submit, and file IND Safety Reports, SUSAR reports, and other interim safety reports with the appropriate IRB and study files.
• Coordinate monitor visits by providing access to study files, maintaining Monitor Visit Logs when applicable, supporting monitors during visits, and updating relevant study systems when monitor assignments change.
• Process incoming monitor letters, route documents for investigator signatures when required, and ensure appropriate filing within the ISF.
• Maintain training documentation, including protocol-specific, EDC, and CITI training records.
• Track investigator and study staff CVs, licenses, certifications, and other required credentials.
• Manage CITI training completion by sending renewal reminders and following up with study personnel until requirements are satisfied.
• Intake revised study documents such as amendments, protocol letters, notes to file, and Investigator’s Brochures and coordinate their preparation for IRB submission.
• Stamp and file revised documents, update electronic repositories and databases, notify study teams, maintain document tracking spreadsheets, and create or update tasks in OnCore as needed.
• Complete and coordinate investigator signatures for updated Form FDA 1572s and Financial Disclosure Forms.
• Maintain laboratory certifications and normal ranges associated with laboratories listed on Form FDA 1572s, including tracking CVs and licenses for laboratory directors.
• Prepare study files for archiving by conducting final quality assurance checks and verifying that required documentation and records are complete and properly inventoried.
• Support regulatory documentation throughout the study lifecycle while maintaining accuracy, confidentiality, timeliness, and compliance with applicable requirements.

Requirements

• High school diploma or equivalent is required.
• Demonstrate proficient working knowledge of Microsoft Word and strong general computer skills.
• Possess excellent organizational skills and the ability to manage multiple documentation-related tasks while meeting deadlines.
• Be highly detail-oriented with strong spelling, writing, composition, proofreading, and document-review skills.
• Demonstrate the ability to understand instructions, work independently with minimal supervision, compose professional reports and correspondence, and follow established processes accurately.
• Communicate clearly and professionally with investigators, study teams, monitors, sponsors, CROs, and other stakeholders.
• Demonstrate reliability, strong follow-through, and a proactive approach to completing time-sensitive regulatory activities.
• Be comfortable spending extended periods sitting, typing, and working at a computer.

Benefits

• $22–$24 per hour for this remote position, with actual compensation potentially varying based on market location, job-related knowledge, skills, and experience.
• Full-time, remote work opportunity.
• Monday–Friday schedule, 8:00 AM–4:30 PM EST.
• 401(k) retirement savings plan with employer match.
• Eligibility for an annual performance bonus based on role and organizational results.
• Generous paid time off and paid holidays.
• Comprehensive medical, dental, and vision coverage, plus optional insurance plans.
• Company-paid life and disability insurance.
• Employee Assistance Program (EAP) providing confidential support for employees and their families from day one.
• Flexible FSA and HSA plans to support financial wellness.
• A supportive and flexible work environment that values employee wellbeing and work-life balance.
• Opportunities for continuous learning, professional growth, collaboration, and contribution within a mission-driven clinical research environment.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1